Fassier-Duval Telescopic IM System

Rod, Fixation, Intramedullary And Accessories

Pega Medical Inc.

The following data is part of a premarket notification filed by Pega Medical Inc. with the FDA for Fassier-duval Telescopic Im System.

Pre-market Notification Details

Device IDK211292
510k NumberK211292
Device Name:Fassier-Duval Telescopic IM System
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant Pega Medical Inc. 1111 Autoroute Chomedey Laval,  CA H7w 5j8
ContactEnrique Garcia
CorrespondentEnrique Garcia
Pega Medical Inc. 1111 Autoroute Chomedey Laval,  CA H7w 5j8
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-28
Decision Date2021-05-26

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